Manufacturing Operations Lead - GMP Medical Devices

Integra LifeSciences Corporation; Mansfield (MA); On-site; USD 81,650 - 112,700; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Life insurance

Short-/Long-term disability

401(k) plan

Job summary

Integra LifeSciences Corporation in Mansfield, MA is seeking a Supervisor, Manufacturing Operations to lead daily production in Machining, Packaging, Boxing, and related areas for multiple product lines. You will ensure safety, quality, on-time delivery, and cost control while guiding a team in a GMP, ISO-regulated environment.

Candidates should have a Bachelor's in Science/Engineering, 3+ years in GMP leadership, knowledge of NCs/CAPAs, and experience in cleanrooms (ISO 7/5).

Qualifications

• Bachelor’s degree or higher in Science, Engineering, or related fields is desired or equivalent combination of education and relevant leadership experience in a regulated environment will be considered.
• 3+ years of relevant leadership experience in a GMP regulated industry.
• Knowledge of NCs and CAPAs.
• Must have strong written and verbal communication skills.
• Must possess strong leadership skills with team-focused attitude and approach.
• Must be able to gown into ISO 7 and ISO 5 Clean Room gowning.
• Batch manufacturing experience.
• Demonstrated knowledge of FDA regulations, ISO 9001, ISO 13485, and other National and International regulations and standards.
• Strong computer skills, including Microsoft Office experience required.
• Automation experience a preferred.
• Knowledge of Oracle R12/Agile preferred.
• Understanding of Lean/six Sigma a plus.

Responsibilities

• Direct daily production activities and staff in Machining, Packaging, Boxing areas for multiple product lines.
• Ensure daily production goals are met and report progress at shift and tier meetings.
• Operate, maintain, troubleshoot process equipment and make minor adjustments as needed.
• Maintain logs, log books and records for WIP activities and inventories.
• Lead operations in cleanroom environment and ensure proper environmental controls.
• Support Non-Conformance/CAPA/Audit investigations.
• Maintain records to comply with GMP and Quality Systems Regulations.
• Plan and lead manufacturing process improvements and Lean initiatives.
• Collaborate with cross-functional teams and coach staff.

Skills

Leadership

GMP knowledge

Regulatory knowledge

Communication

Cleanroom gowning

Education

Bachelor’s degree in Science or Engineering

Tools

Oracle R12/Agile

Microsoft Office

Job description

Integra LifeSciences Corporation in Mansfield, MA is seeking a Supervisor, Manufacturing Operations to lead daily production in Machining, Packaging, Boxing, and related areas for multiple product lines. You will ensure safety, quality, on-time delivery, and cost control while guiding a team in a GMP, ISO-regulated environment.

Candidates should have a Bachelor's in Science/Engineering, 3+ years in GMP leadership, knowledge of NCs/CAPAs, and experience in cleanrooms (ISO 7/5).